MONTELUKAST SODIUM Drug Patent Profile
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Which patents cover Montelukast Sodium, and what generic alternatives are available?
Montelukast Sodium is a drug marketed by Ajanta Pharma Ltd, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Mylan Pharms Inc, Teva Pharms, Torrent, Amneal Pharms, Anbison Lab, Apotex Inc, Chartwell Molecular, Hetero Labs Ltd V, Hikma, Jubilant Generics, Lannett Co Inc, Macleods Pharms Ltd, Rising, Sandoz Inc, Strides Pharma, Torrent Pharms Ltd, Unichem, Unimark Remedies Ltd, Accord Hlthcare, Apotex Corp, Breckenridge, Cipla, Glenmark Generics, Graviti Pharms, and L Perrigo Co. and is included in forty-nine NDAs.
The generic ingredient in MONTELUKAST SODIUM is montelukast sodium. There are thirty-five drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the montelukast sodium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Montelukast Sodium
A generic version of MONTELUKAST SODIUM was approved as montelukast sodium by AUROBINDO PHARMA LTD on August 3rd, 2012.
Summary for MONTELUKAST SODIUM
| US Patents: | 0 |
| Applicants: | 28 |
| NDAs: | 49 |
| Finished Product Suppliers / Packagers: | 40 |
| Raw Ingredient (Bulk) Api Vendors: | 88 |
| Clinical Trials: | 81 |
| Patent Applications: | 4,166 |
| Formulation / Manufacturing: | see details |
| Drug Sales Revenues: | Drug sales revenues for MONTELUKAST SODIUM |
| DailyMed Link: | MONTELUKAST SODIUM at DailyMed |
Recent Clinical Trials for MONTELUKAST SODIUM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Mansoura University Children Hospital | Phase 1 |
| Zibo Central Hospital | Phase 4 |
| The Children's Hospital of Zhejiang University School of Medicine | Phase 4 |
Pharmacology for MONTELUKAST SODIUM
| Drug Class | Leukotriene Receptor Antagonist |
| Mechanism of Action | Leukotriene Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for MONTELUKAST SODIUM
Paragraph IV (Patent) Challenges for MONTELUKAST SODIUM
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| SINGULAIR | Oral Granules | montelukast sodium | 4 mg | 021409 | 1 | 2008-10-17 |
| SINGULAIR | Tablets | montelukast sodium | 10 mg | 020829 | 2 | 2007-02-20 |
| SINGULAIR | Chewable Tablets | montelukast sodium | 4 mg and 5 mg | 020830 | 1 | 2006-12-26 |
US Patents and Regulatory Information for MONTELUKAST SODIUM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Torrent Pharms Ltd | MONTELUKAST SODIUM | montelukast sodium | TABLET, CHEWABLE;ORAL | 090984-001 | Aug 3, 2012 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Mylan Pharms Inc | MONTELUKAST SODIUM | montelukast sodium | TABLET, CHEWABLE;ORAL | 079142-002 | Aug 3, 2012 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Amneal Pharms | MONTELUKAST SODIUM | montelukast sodium | TABLET;ORAL | 204604-001 | Sep 4, 2015 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Hikma | MONTELUKAST SODIUM | montelukast sodium | TABLET;ORAL | 090655-001 | Aug 3, 2012 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Unimark Remedies Ltd | MONTELUKAST SODIUM | montelukast sodium | TABLET, CHEWABLE;ORAL | 203037-001 | Oct 30, 2014 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Anbison Lab | MONTELUKAST SODIUM | montelukast sodium | TABLET;ORAL | 205683-001 | Jan 12, 2016 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
